Heart Failure; With DecompensationRADARNCT03103932
Biomarker Guided Discharge of Heart Failure Patients
A study testing Biomarker guided discharge algorithm in people with Heart Failure; With Decompensation, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
This is a multi-centre, single blind, randomized study. Patients admitted to hospital with acute decompensated heart failure will be randomized to biomarker guided discharge algorithm vs usual care in a 2:1 ratio. NTproBNP and other biomarkers will be measured within 24 hours of admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure; With Decompensation
- What is being tested?
- Biomarker guided discharge algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteCanada
- Study dates
- 26 Aug 2017to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to hospital with a primary diagnosis of acute decompensated heart failure, compatible with the modified Framingham criteria
Who cannot join
- Patient unable to provide blood samples or cannot participate in follow-up
- Patient with end stage organ failure
- Kidney: creatinine >350 μmol/L or Estimated GFR ≤15 ml/min
- Liver dysfunction: liver function test >2.5 times normal
- Lungs: pulmonary FEV1<50% predicted
- Patient requiring intubation
Show all 13Show fewer
- Patient with an admission NTproBNP measurement of >30,000 pg/ml
- Patient listed for heart transplant, or admitted specifically for transplant workup
- Patient in cardiogenic shock
- Patient with life expectancy of less than 6 months, or has major co-morbidities such as new stroke, cancer, pneumonia, or other serious life threatening illness
- Patient with conditions that will make it difficult to discharge from hospital such as a fall or waiting for a long term care bed
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the trial, or may bias the result of the trial, or the patient's ability to participate in the trial
- Patient who has participated in another research trial involving an investigational product in the past 30 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Ermina Moga, MD, 613-696-7000 ext. 10945, emoga@ottawaheart.ca
About this study
Official title: BiomarkeR cAndidates to Guide Discharge of Patients Admitted to Hospital With heARt Failure
This is a multi-centre, single blind, randomized study. Patients admitted to hospital with acute decompensated heart failure will be randomized to biomarker guided discharge algorithm vs usual care in a 2:1 ratio. NTproBNP and other biomarkers will be measured within 24 hours of admission. The NTproBNP results will be used to further stratify participants randomized to the biomarker guided group into lower and medium to higher risk pathways. Biomarkers will be repeated after 2-3 days and again prior to discharge. Specific care pathways will be followed for each of the lower risk and medium-higher risk groups. Biomarkers will be repeated 30 days post discharge. Participants will be followed with a phone call at 3 months and return for a follow up visit at 6 months post discharge for outcome evaluation.
Read the detailed description
Care Pathways:
Usual care: Participants will be treated for their heart failure symptoms as is usual at each participating institution. NTproBNP results will not be revealed to the care providers.
NTproBNP levels of participants randomized to the biomarker guided discharge algorithm will be posted on the participant's medical records. The results will be used by the care providers for decision making according to the predetermined care pathway.
Lower risk group: Participants who's admission NTproBNP is below 3,000 pg/ml will be placed into the lower risk group. Discharge planning will start within 24 hours of hospital admission. Symptoms will be treated aggressively. If the NTproBNP level drops to 1,500 pg/ml or below on Day 2-3, the participant will be discharged home. If the NTproBNP level does not drop to below 1,500 pg/ml, the participant will continue on treatment for another day or two and be discharged home when medically stabilized.
Medium-higher risk group: Participants who's admission NTproBNP is 3,000 pg/ml or above will be placed into the medium-higher risk group. Symptoms will be treated aggressively. If the NTproBNP level drops to below 3,000 pg/ml on Day 2-3, the participant will follow the lower risk pathway until discharge. If the NTproBNP level remains above 3,000 pg/ml, aggressive treatment of symptoms will continue. Biomarkers will be repeated on Day 6-7. If the NTproBNP level has dropped by at least 30% from admission and the participant is medically stabilized, the participant will be discharged home. If the NTproBNP level has not dropped by at least 30% from admission, treatment will continue until the participant is medically stabilized. This last group will be discharged home on telehealth with daily monitoring.
All participants will complete a Quality of Life questionnaire at admission and at the 30 day post discharge follow up.
- Conditions
- Heart Failure; With Decompensation
- Being tested
- Biomarker guided discharge algorithm
- Keywords
- biomarkers, heart failure, hospital admission
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker guided discharge algorithmOther
participants randomized to the biomarker guided discharge algorithm will follow a pre-determined care pathway for treatment of heart failure symptoms based on admission NTproBNP levels
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Participants will be treated as is usual at each institution. Biomarkers will be measured on Day 2-3 and again prior to discharge from hospital. NTproBNP levels will not be revealed to care providers. |
| Biomarker guided discharge pathway | Experimental | Admission NTproBNP levels will be used to stratify participants into lower and medium-higher risk care pathways. NTproBNP levels will be repeated on Day 2-3 and again prior to discharge. Each care pathway is designed to optimize discharge time according to NTproBNP levels. All NTproBNP results will be displayed on the front of the participant's chart along with the care pathway that the participant has been randomized to. The care providers will be reminded daily by the study team that the participant is in the biomarker guided discharge pathway arm of the study and that the designated care pathway should be followed as closely as possible. Receives: Other: Biomarker guided discharge algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis
The investigator will measure te total number of days in hospital for each group
Measured: Randomization to 30 days post randomization
the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis
The investigator will measure the number of rehospitalizations in each group
Measured: Randomization to 30 days post randomization
the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis
The investigator will measure the total number of deaths and hospitalization episodes in each group
Measured: Randomization to 30 days post randomization
Secondary outcomes (3)
the total number of days alive and out of hospital during the first 6 months of follow up
The investigator will measure the total number of days in hospital in each group
Measured: Randomization to 6 months post randomization
the total number of days alive and out of hospital during the first 6 months of follow up
The investigator will measure The number of rehospitalizations in each group
Measured: Randomization to 6 months post randomization
the total number of days alive and out of hospital during the first 6 months of follow up
The investigator will measure the number of deaths/hospitalization episodes in each group
Measured: Randomization to 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start26 Aug 2017
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure; With DecompensationStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single blind, strategy based, randomized trial consisting of two main study arms
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Genome Canada, Roche Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- Peter Liu, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103932
- Sponsor's protocol ID
- 806
- Acronym
- RADAR
- Status last verified
- Jan 2026
- First submitted
- 28 Mar 2017
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be available to other researchers. Only results will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BiomarkeR cAndidates to Guide Discharge of Patients Admitted to Hospital With heARt Failure
- ClinicalTrials.gov ID
- NCT03103932
- Acronym / sponsor ID
- RADAR / 806
- Conditions
- Heart Failure; With Decompensation
- Keywords
- biomarkers, heart failure, hospital admission
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Genome Canada, Roche Diagnostics GmbH
- Study start
- 26 Aug 2017 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-centre, single blind, randomized study. Patients admitted to hospital with acute decompensated heart failure will be randomized to biomarker guided discharge algorithm vs usual care in a 2:1 ratio. NTproBNP and other biomarkers will be measured within 24 hours of admission. The NTproBNP results will be used to further stratify participants randomized to the biomarker guided group into lower and medium to higher risk pathways. Biomarkers will be repeated after 2-3 days and again prior to discharge. Specific care pathways will be followed for each of the lower risk and medium-higher risk groups. Biomarkers will be repeated 30 days post discharge. Participants will be followed with a phone call at 3 months and return for a follow up visit at 6 months post discharge for outcome evaluation.
Detailed description
Care Pathways:
Usual care: Participants will be treated for their heart failure symptoms as is usual at each participating institution. NTproBNP results will not be revealed to the care providers.
NTproBNP levels of participants randomized to the biomarker guided discharge algorithm will be posted on the participant's medical records. The results will be used by the care providers for decision making according to the predetermined care pathway.
Lower risk group: Participants who's admission NTproBNP is below 3,000 pg/ml will be placed into the lower risk group. Discharge planning will start within 24 hours of hospital admission. Symptoms will be treated aggressively. If the NTproBNP level drops to 1,500 pg/ml or below on Day 2-3, the participant will be discharged home. If the NTproBNP level does not drop to below 1,500 pg/ml, the participant will continue on treatment for another day or two and be discharged home when medically stabilized.
Medium-higher risk group: Participants who's admission NTproBNP is 3,000 pg/ml or above will be placed into the medium-higher risk group. Symptoms will be treated aggressively. If the NTproBNP level drops to below 3,000 pg/ml on Day 2-3, the participant will follow the lower risk pathway until discharge. If the NTproBNP level remains above 3,000 pg/ml, aggressive treatment of symptoms will continue. Biomarkers will be repeated on Day 6-7. If the NTproBNP level has dropped by at least 30% from admission and the participant is medically stabilized, the participant will be discharged home. If the NTproBNP level has not dropped by at least 30% from admission, treatment will continue until the participant is medically stabilized. This last group will be discharged home on telehealth with daily monitoring.
All participants will complete a Quality of Life questionnaire at admission and at the 30 day post discharge follow up.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- single blind, strategy based, randomized trial consisting of two main study arms
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Participants will be treated as is usual at each institution. Biomarkers will be measured on Day 2-3 and again prior to discharge from hospital. NTproBNP levels will not be revealed to care providers. |
| Biomarker guided discharge pathway | Experimental | Other: Biomarker guided discharge algorithmAdmission NTproBNP levels will be used to stratify participants into lower and medium-higher risk care pathways. NTproBNP levels will be repeated on Day 2-3 and again prior to discharge. Each care pathway is designed to optimize discharge time according to NTproBNP levels. All NTproBNP results will be displayed on the front of the participant's chart along with the care pathway that the participant has been randomized to. The care providers will be reminded daily by the study team that the participant is in the biomarker guided discharge pathway arm of the study and that the designated care pathway should be followed as closely as possible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to hospital with a primary diagnosis of acute decompensated heart failure, compatible with the modified Framingham criteria
Key exclusion criteria (13 listed)
- Patient unable to provide blood samples or cannot participate in follow-up
- Patient with end stage organ failure
- Patient requiring intubation
- Patient with an admission NTproBNP measurement of >30,000 pg/ml
- Patient listed for heart transplant, or admitted specifically for transplant workup
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker guided discharge algorithmparticipants randomized to the biomarker guided discharge algorithm will follow a pre-determined care pathway for treatment of heart failure symptoms based on admission NTproBNP levels | Other | Biomarker guided discharge pathway |
Primary outcome
the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis
Time frame: Randomization to 30 days post randomization
The investigator will measure te total number of days in hospital for each group
the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis
Time frame: Randomization to 30 days post randomization
The investigator will measure the number of rehospitalizations in each group
the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis
Time frame: Randomization to 30 days post randomization
The investigator will measure the total number of deaths and hospitalization episodes in each group
3 secondary outcomes
the total number of days alive and out of hospital during the first 6 months of follow up
Time frame: Randomization to 6 months post randomization
the total number of days alive and out of hospital during the first 6 months of follow up
Time frame: Randomization to 6 months post randomization
the total number of days alive and out of hospital during the first 6 months of follow up
Time frame: Randomization to 6 months post randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. IPD will not be available to other researchers. Only results will be shared.
Related trials for Heart Failure; With Decompensation
Not yet recruiting
Exercise, Mediterranean Diet and Inflammation in Heart Failure
Heart Failure, Heart Failure Preserved Ejection Fraction
Recruiting
Remote Dielectric Sensing (ReDS) Assisted Diuresis in Acute Decompensated Heart Failure
Heart Failure; With Decompensation
Recruiting
Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
Heart Failure, Cardiorenal Syndrome
Recruiting
Acquisition of Cardiac Function Parameters in MRI and Echocardiography in Patients With Ethyltoxic Liver Cirrhosis and Transjugular Intrahepatic Portosystemic Shunt (TIPSS) Placement
MASLD, Liver Cirrhosis, Alcoholic
Active, not recruitingObservational study
Association Between the Sit-To-Stand Test and the Prognosis of Patients With Heart Failure
Heart Failure, Heart Failure NYHA Class IV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Liu, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomarker guided discharge algorithm in people with Heart Failure; With Decompensation, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ermina Moga, MD (613-696-7000 ext. 10945, emoga@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the total number of days alive and out of hospital during the first 30 days of heart failure diagnosis (time frame: Randomization to 30 days post randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.